Exact Imaging Inc

FDA Filings

This page includes the latest FDA filings for Exact Imaging Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012402886
FEI Number3012402886
NameEXACT IMAGING, INC.
Owner & OperatorExact Imaging, Inc.
Contact Address7676 Woodbine Avenue Unit 15
Markham CA-ON Ontario L3R 2N2 CA
Official Correspondent
  • Sam Rajkumar
  • 1-905-4150030-278
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7676 Woodbine Avenue Unit 15
Markham Ontario, L3R 2N2 CA
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Exact Imaging Inc
Non-Sterile Reusable Needle Guide - 16GA EV-BIOG-R162022-05-23
Exact Imaging Inc
Sterile transrectal needle guide with sheath EV-29L-TRK-12021-02-11
Exact Imaging Inc
Sterile transperineal needle guide with sheath EV-29L-TPK-12021-02-11
Exact Imaging Inc
EV5C Abdominal Transducer EV-5C2021-02-11
Exact Imaging Inc
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer EV-BIOGR2019-12-23
Exact Imaging Inc
Needle Guide for use with the Exact Imaging EV29L Transducer EV-BIOG-12019-10-07
EXACT IMAGING, INC.
ExactVu High Resolution Micro-Ultrasound System2019-10-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-10-07
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Reusable Transrectal Needle Guide (16 & 18 GA)2019-10-07
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-10-07
EXACT IMAGING, INC.
ExactVu High Resolution Micro-Ultrasound System2019-10-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-10-07
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Reusable Transrectal Needle Guide (16 & 18 GA)2019-10-07
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-10-07
EXACT IMAGING, INC.
ExactVu High Resolution Micro-Ultrasound System2019-10-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-10-07
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Reusable Transrectal Needle Guide (16 & 18 GA)2019-10-07
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-10-07
EXACT IMAGING, INC.
ExactVu High Resolution Micro-Ultrasound System2019-10-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-10-07
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide2019-10-07
EXACT IMAGING, INC.
EV29L Sterile Transperineal Needle Guide Kit2019-10-07
EXACT IMAGING, INC.
EV29L Reusable Transrectal Needle Guide (16 & 18 GA)2019-10-07
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-10-07
Exact Imaging Inc.
ExactVu High Resolution Micro-Ultrasound System2019-10-01
EXACT IMAGING, INC.
Transperineal Transducer Cradle2019-06-17
EXACT IMAGING, INC.
Transperineal Stepper2019-06-17
EXACT IMAGING, INC.
Transperineal Reusable Template2019-06-17
EXACT IMAGING, INC.
Transperineal Disposable Template2019-06-17
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2019-05-27
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-05-27
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-05-27
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-05-27
EXACT IMAGING, INC.
EV29L Non-Sterile Reusable Transrectal Needle Guides2019-05-27
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-05-27
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2019-05-27
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-05-27
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-05-27
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-05-27
EXACT IMAGING, INC.
EV29L Non-Sterile Reusable Transrectal Needle Guides2019-05-27
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-05-27
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2019-05-27
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-05-27
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-05-27
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-05-27
EXACT IMAGING, INC.
EV29L Non-Sterile Reusable Transrectal Needle Guides2019-05-27
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-05-27
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2019-05-27
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2019-05-27
EXACT IMAGING, INC.
EV5C Abdominal Transducer2019-05-27
EXACT IMAGING, INC.
EV29L Sterile Transrectal Needle Guide2019-05-27
EXACT IMAGING, INC.
EV29L Non-Sterile Reusable Transrectal Needle Guides2019-05-27
EXACT IMAGING, INC.
EV29L High Resolution Side-Fire Transducer2019-05-27
Exact Imaging, Inc.
ExactVu High Resolution Micro-Ultrasound System2019-05-10
EXACT IMAGING, INC.
SHEATHES (NON-LATEX), STERILE2019-04-26
Exact Imaging Inc
EV9C Transrectal Transducer EV-9C2018-07-06
Exact Imaging Inc
EV29L Transrectal Transducer EV-29L2018-07-06
Exact Imaging Inc
ExactVu High Resolution Micro-Ultrasound System EV-SYS-1202018-07-06
Exact Imaging Inc
ExactVu High Resolution Micro-Ultrasound System EV-SYS-2202018-07-06
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2018-05-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2018-05-07
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L Reusable Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire Transducer2018-05-07
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2018-05-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2018-05-07
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L Reusable Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire Transducer2018-05-07
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2018-05-07
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2018-05-07
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L Reusable Needle Guide2018-05-07
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire Transducer2018-05-07
Exact Imaging Inc.
ExactVu High Resolution Micro-Ultrasound System2018-04-30
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2017-01-05
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2017-01-05
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2017-01-05
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire transducer2017-01-05
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2017-01-05
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2017-01-05
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2017-01-05
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire transducer2017-01-05
EXACT IMAGING, INC.
ExactVu? High Resolution Micro-Ultrasound System2017-01-05
EXACT IMAGING, INC.
EV9C Transrectal End-Fire Transducer2017-01-05
EXACT IMAGING, INC.
EV29L Sterile Biopsy Needle Guide2017-01-05
EXACT IMAGING, INC.
EV29L High Resolution Transrectal Side-Fire transducer2017-01-05

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